sub-study NCI Cell Therapy Worshop

Request for Approval under the Generic Clearance for the “Conference, Meeting, Workshop, and Poster Session Registration Generic Clearance (OD)”(OMB#: 0925-0740, Expiration Date: 07/31/2022)

TITLE OF INFORMATION COLLECTION: Registration for the 2^nd NCI Workshop on Cell-Based Immunotherapy for Solid Tumors

PURPOSE: Cell-based immunotherapies have had remarkable success in the clinic, specifically in the treatment of hematologic malignancies. However, these strategies have had limited efficacy in patients with solid tumors. To better understand the challenges involved and how to facilitate further progress in the field, NCI is holding a workshop (organized by DCTD) on December 10-11, 2020 to engage in an interactive dialogue with intramural and extramural researchers. This virtual meeting will review current efforts in the development of autologous and allogeneic cell-based therapies, including cutting-edge technologies for designing, testing, and manufacturing cell therapies. The goal of the meeting is to identify knowledge gaps, resource needs, and critical barriers in the field, providing the basis for NCI to better support the extramural community and accelerate progress toward the treatment of solid tumors.

Session topics will include:

• Target Identification and Selection

• Safety Assessments and Toxicities

• Tumor Microenvironment and Cell Trafficking

• Immune Cell Fitness/Persistence and Monitoring Approaches

• Cell Product Manufacturing

• Regulatory and Clinical Aspects

DESCRIPTION OF RESPONDENTS: PIs/researchers, clinicians, and trainees (postdocs, fellows, and medical/graduate students) from government, academia, and industry

TYPE OF COLLECTION:

[ ] Abstract [ ] Application

[X] Registration Form [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

Name: Laura Hunter

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [X] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] No

Amount: N/A

Explanation for incentive: N/A

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Individuals	500	1	5/60	42
Totals		500		42

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	42	$46.95	$1,971.90
Total			$1,971.90

*Source of the mean Hourly Wage Rate is provided by the Bureau of Labor Statistics, Occupation title “Medical Scientists” 19-1040, https://www.bls.gov/oes/2019/May/oes_nat.htm#00-0000.

FEDERAL COST: The estimated annual cost to the Federal government is $1,577.09.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/10	$157,709	1%		$1,577.09
Contractor Cost					$0
Travel					$0
Other Cost					$0
Total					$1,577.09

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/20Tables/html/DCB.aspx

Administration of the Instrument

How will you collect the information? (Check all that apply)

[X] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Survey Form

[ ] Chart Abstraction

[ ] Other, Explain

Will interviewers, facilitators, or research coordinators be used? [ ] Yes [X] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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